Back in the 1980s and early 1990s, the outbreak of HIV (human immunodeficiency virus) and AIDS (acquired immunodeficiency syndrome) swept through the nation. HIV and AIDS were a death sentence, and there was a national panic to find a cure.

Today, about 1.1 million people in the United States are living with HIV. There is still no cure for AIDS and HIV. However, the disease has declined in recent years due to drugs like tenofovir disoproxil fumarate (TDF), which effectively stopped the spread of HIV.

TDF is an HIV drug marketed by the pharmaceutical company Gilead Sciences, Inc. TDF has been sold under several brand names, including Truvada, Viread, and Atripla, among others. The Truvada drug is the most popular and the most prescribed in the marketplace.

First approved by the Food and Drug Administration (FDA) in 2001, Truvada is considered a front-line drug for patients with HIV. It was designed to stop HIV cells from multiplying in the body. Although Truvada doesn’t cure AIDS or HIV, it does prevent HIV from developing into full-blown AIDS.

Truvada is also used to prevent HIV contraction. Studies show that Truvada PrEP (Pre-exposure prophylaxis) can reduce the risk of HIV infection by 92%.

PrEP is recommended for those who are at high risk of contracting HIV. This applies primarily to healthy gay or bisexual men, intravenous drug users who share needles, and heterosexual men and women who don’t use condoms while having sex with high-risk partners.

Although Truvada has been successful in treating and preventing HIV and AIDS, it also presents some health complications. Truvada uses have been linked to many adverse side effects. Some common but less severe side effects include:

• Abdominal pain
• Abnormal dreams
• Depression
• Diarrhea
• Difficulty breathing
• Difficulty sleeping
• Dizziness
• Fatigue or weakness
• Headache
• Liver problems
• Low energy
• Muscle pain
• Nausea
• Skin rash
• Weight loss

Truvada can also cause some serious side effects, which can lead to severe health complications with the patient’s kidneys and bone structures. They include:

• Osteoporosis and Decreased Bone Density – Truvada is intended to be used for a lengthy period. Since Truvada is prescribed in high dosages, the toxicity of the drug can slowly deteriorate the bone structure, leading to brittle or broken bones.
• Kidney damage and renal failure – The kidneys’ main job is to flush out extra fluid and harmful waste from your body. Truvada puts a lot of stress on the kidneys, which can lead to kidney damage and kidney failure.
• Lactic acidosis – Without the kidneys working correctly, insufficient lactate acid will be removed from the bloodstream, which can cause an accumulation. The buildup can also alter the pH balance in the body, which can lead to other medical complications such as muscle weakness, rapid breathing, or coma.

Studies have shown that those who take Truvada are more prone to broken bones and kidney failure than other HIV positive patients who are not using Truvada. One study found that in the first two years of Truvada treatment, patients’ bone mineral density declined by 2-6 percent. Another study out of the University of California in San Francisco investigated the outcomes of 10,000 HIV-positive patients. It concluded that Truvada increases the risk for a rapid decline in kidney function, kidney failure, and chronic kidney disease.

Gilead Scientific received an FDA warning letter on three separate occasions to minimize the risk of broken bones and kidney failure from Truvada:

• March 2002 – The drug company was reprimanded for making misleading and false statements. Sales representatives claimed that the drug was extremely safe and had no toxicities. They made no mention of the risk of bone fractures, even though the dangers were included in the drug’s warning label and had been documented through clinical research.
• July 2003 – The second notice cited the recurrence of the same issue in 2002. Gilead was asked to provide an apparent response to why sales representatives continue to downplay the danger of the drug and promote it for non-approved use.
• June 2014 – The third warning was issued regarding a web link that advertised the drug’s safety yet failed to mention the risk of kidney problems from Truvada. The company was ordered to remove the link.

While people may be aware of the risks and side effects of taking Truvada, what they don’t realize is that a safer new drug was developed shortly after Truvada first hit the marketplace in the United States. The new drug, TAF (tenofovir alafenamide), showed promising outcomes in early clinical trials and a significantly reduced risk for severe side effects compared to Truvada.

Despite the promising result, the development of TAF was halted in 2004 and didn’t resume again until 2010. According to critics, Gilead purposely withheld TAF to protect its market dominance of the tenofovir patent and to “milk” Truvada. Gilead’s delay of the safer drug caused many people to suffer severely broken bones and chronic kidney issues for a decade longer. 

Many Truvada defective drug lawsuits have been filed against Gilead for failing to warn patients about the adverse side effects of Truvada, including a class-action lawsuit in California.

The lawsuits claim that the pharmaceutical company had developed a safer drug but withheld it for a decade until Truvada’s patent was about to expire to maximize their profits. 

The majority of these lawsuits claim that Gilead knew Truvada was toxic and even pursued a safer version. Still, the company continued to push Truvada as a risk-free miracle drug, even after the FDA chastised them for making false and misleading statements.

Drug companies have a legal responsibility to warn consumers about the risks of taking their drugs. The disclosures will help doctors make better recommendations and allow patients to make informed decisions. But drug manufacturers know that doing so can deter people and hurt their profits.

A considerable part of the failure to warn lawsuit deals with Gilead’s concealment of the safer drug, TAF. Studies found that TAF is less toxic and more easily absorbed in the body. The drug company had been examining TAF even before Truvada was approved by the FDA. But Truvada and other TDF-based drugs had recently been patented with years of protection against generic brands. Also, TDF was the dominant HIV treatment drug, which allowed the drug company to charge higher prices. That’s why Gilead covered up TAF rather than release the studies that found the new drug was the safer alternative to TDF.

In 2010, with the patent on Truvada set to expire, Gilead finally announced their new, safer drug. It unveiled the results of its studies on TAF, which was done years earlier, as the new revolutionary treatment for HIV. Gilead urged people who were on Truvada and other TDF-based drugs to switch to the newer and safer TAF-based drugs like Genvoya, Odefsey, and Descovy.

The concealed development of TAF not only suggests that Gilead knew TDF carried significant risks, but it also severely injured those who took Truvada and other TDF-based drugs. For years, the victims were put at risk for bone fractures, osteoporosis, lactic acidosis, kidney damage, and renal failure because Gilead wanted to make more money until the patent on Truvada ran out.

Truvada patients had likely suffered severe injuries and incurred high medical bills. Filing a Truvada injury lawsuit against Gilead can help recover compensation for the losses, pain, and suffering the patients have sustained.

The compensatory damages include:

• Current and future medical expenses
• Loss of consortium
• Lost wages
• Pain and suffering
• Punitive damages

If you are taking Truvada or other TDF-based HIV treatment drugs and are suffering from any adverse side effects, you should reach out to a Truvada injury attorney to find out about your options. Drug companies have a legal duty to caution people about the risks associated with their drugs. When they withhold information, people can get injured through no fault of their own. It’s essential to hold these companies responsible for their actions and have them compensate the patients.

The popular television show The Doctors discussed the antiretroviral drug PrEP and its effectiveness. Watch the video below:

Below are ten of the most frequently asked questions about Truvada. 

Why would someone need to take Truvada? 

Truvada is highly effective at blocking HIV. If you are HIV-negative, you would take the drug before you are exposed to something that causes an HIV infection.

How does Truvada work?

Truvada prevents HIV from making copies of itself in the body by obstructing the HIV reverse transcriptase enzyme. When the enzyme is blocked, it prevents HIV from multiplying.

How long do you take Truvada?

Studies show that it takes about seven days for Truvada to reach high levels of protection in the body. When taken daily as directed, Truvada provides a 92-percent to 99-percent reduction in HIV-risk individuals. 

How much does Truvada cost?

Truvada is not cheap. It costs about $1300 monthly and is covered under most insurance plans. Those who don’t have insurance or have high co-pays can receive payment assistance from Gilead. 

Who is at risk for the severe Truvada side effects?

Anyone who takes Truvada is at risk. However, studies show that people with pre-existing kidney damage or people of color may be more at risk for broken bones and kidney failure from Truvada.

How long does it take for Truvada to leave my system?

Studies suggest that if you take the drug every day, it usually reaches maximum protection in 20 days in blood, about 7 days in rectal tissues, and about 20 days in vaginal tissues.

Anyone or a family member of the individual who has experienced severe side effects such as osteoporosis, kidney failure, or broken bones while using Truvada may file a lawsuit against Gilead.

Many people injured by Truvada usually wonder if the claim falls under a class action lawsuit, often resulting in small compensation. Truvada lawsuits will likely be merged as multi-district litigation (MDL), where each plaintiff receives a settlement based on his or her damages and injuries incurred by Truvada.

Most attorneys work on a contingency basis, meaning there are no upfront fees. We only collect a legal fee if we win compensation for your case.

It’s better to file a lawsuit sooner than later since California law has statutes of limitations that could prohibit you from filing if you wait too long. The statute of limitations in California to file a personal injury case is two years. Most people who have used Truvada in HIV treatment will likely fall within these time limits if they contact a Truvada injury lawyer soon.

Truvada and other TDF-based drugs have been found to cause osteoporosis, broken bones, or kidney problems. Those who have suffered from these severe side effects may be eligible for compensation. If you or a loved one has been taking Truvada and is experiencing adverse effects, you’ll need the guidance of an experienced Truvada lawyer. Call our law firm for free friendly advice at (415) 805-7284 or (800) 404-5400.

^{Editor’s Note: updated 11.14.23 Photo by Pixabay cha [cs 1958]}